细辛脑注射剂质量评价与标准现状分析  

Quality Evaluation and Study on Current Standards of Asarone Injection

作　　者：孙春艳 赵亚萍 郭江红 

机构地区：[1]湖北省食品药品监督检验研究院,武汉420062

出　　处：《中国药品标准》2012年第3期181-184,共4页Drug Standards of China

摘　　要：目的:评价细辛脑注射液及注射用细辛脑的质量现状及存在问题,探讨质量标准的适用性,为质量标准提高提供参考。方法:采用法定检验方法结合探索性研究进行样品检验,统计分析检验结果,进行质量风险分析。结果:按照法定标准检验,合格率为100%。探索性研究显示,如采用HPLC法,合格率为96.3%,不合格项目均为含量测定,细辛脑注射剂总体的质量风险较小,冻干粉针的质量风险稍高于注射液。结论:目前细辛脑注射剂的产品质量基本能符合现行标准要求,探索性研究提示现行标准存在缺陷,急需提高,建议增修订鉴别、含量测定、有关物质、细菌内毒素、聚山梨酯80等检验项目。Objective： To evaluate the quality status of Asarone Injection and existing problems. Assessment the suitability of statutory testing methods, give references for standards improvement later. Method： Statutory testing methods and the exploratory research methods were used to examine samples, evaluate the quality status of Asarone Injection from the results. Results ： All of the Asarone Injection qualified through statutory testing methods, but exploratory research suggested that with HPLC 96. 3% of them qualified and assay was the mainly unqualified item. Overall, the quality risk was low, freeze-dried powder of asarone was a little higher. Conclu- sion： The product quality of Asarone Injection can basically meet the current standards, exploratory research suggests that the current standard is imperfect, it is urgent to improve standards by amendment of identification, assay, related substances, bacterial toxins, polysorbate 80 and other test items.

关 键 词：细辛脑注射剂 评价性抽验 质量评价 质量标准 

分 类 号：R921.2[医药卫生—药学]